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A final decision on marketing authorization is anticipated for Q1 of 2025.

“If approved, this approach has the potential to transform the treatment paradigm in prostate cancer, offering patients with localized disease an effective treatment option that may reduce the risk of disease recurrence," says Glen Gejerman, MD, MBA.

The primary aims for the EVANESCE-II trial are to confirm the safety of the FemPulse System and to establish noninferiority to first-line tolterodine.

Specifically, 90% of patients in the HIFU arm vs 86% of patients in the radical prostatectomy arm were free from subsequent definitive treatment at 30 months.

Cretostimogene grenadenorepvec is an investigational oncolytic immunotherapy for patients with BCG-unresponsive high-risk NMIBC.

"The durability response for these patients was impressive given the fact that these patients were those who, by definition and by inclusion criteria, were recurrent within a year at [baseline]," says Sandip M. Prasad, MD.

Test your knowledge of his quiz the Canadian Urological Association's recommendations for germline genetic testing in prostate cancer management.

"Overall, the take-home message is that in patients with BCG-unresponsive non–muscle invasive bladder cancer, you can consider nadofaragene as an option among those that are available for treating these patients," said Vikram Narayan, MD.

The clearance is supported by data from the PRESERVE trial, which evaluated the safety and effectiveness of the NanoKnife System in patients with intermediate-risk prostate cancer.

"We found that the majority of malpractice claims were filed in response to delayed diagnosis or treatment and no cases were filed in response to surveillance practices or surgical techniques," said Adri M. Durant, MD.

CR rate was 98% (39/40) at 3 months, 94% at 6 months (34/36), and 81% at 12 months (21/26).

The priority review decision is based on results of the phase 3 NIAGARA study (NCT03732677).

As centrally assessed, the CR rate was 83.5% (95% CI, 73.9-90.7); the CR rate was 85.9% (95% CI, 76.6-92.5) per investigator assessment.

At month 6, the overall high-grade complete response rate was 72% (13 of 18

The overall complete response rate was 74.5% (95% CI, 65.4%-82.4%).

Anemia was the most frequently observed any-cause AE and was seen in 485 (84.2%) patients.

PT217 is currently under investigation in the phase 1/2 SKYBRIDGE trial in patients with neuroendocrine cancers.

Overall median time from first documented biomarker test date to index date was 5.5 months.

"That pan-tumor approval and this patient case really highlight that in prostate cancer, we should be checking HER2 by immunohistochemistry," says Maneesh R. Jain, MD.

Data showed that all patients achieved a PSA decline of at least 50%.

Ferring has announced the opening of the first clinical trial sites for 2 studies within the ABLE clinical trial program as well as the launch of the phase 1/2 LUNAR trial.

“The combination of pembrolizumab and chemotherapy presents a promising new treatment approach for these challenging-to-treat, rare cancers and could be a major breakthrough for patient care,” says Arnold I. Chin, MD, PhD.

"Most of the published data about HIFU tended to be with relatively short-term follow-up," says Ralph J. Miller Jr, MD.

The phase 2 CELLVX-230 trial is exploring the potential of FK-PC101 to delay or prevent prostate cancer recurrence following prostatectomy.

"The final rule for 2025 poses several challenges to urology. Lobbying efforts to preserve telehealth access and the CF will continue, perhaps dragging into 2025," write Jonathan Rubenstein, MD, and Mark Painter.

“Our study highlights the potential of epigenomic profiling from a simple blood draw to provide a real-time, non-invasive readout of PSMA expression that corresponds with treatment response," says Jacob E. Berchuck, MD.

“The median DOR of 47.8 months in patients who achieved complete response with JELMYTO provides evidence of robust durability in maintaining control of low-grade UTUC over an extended period,” says Phillip Pierorazio, MD.

The study showed significant reductions in both anxiety and depressive symptoms following the intervention.

Data from the CAPItello-281 trial also showed a trend toward an improvement in overall survival.

The trial is evaluating the diagnostic performance of copper Cu 64 PSMA I&T PET/CT in men with suspected biochemical recurrence of prostate cancer following treatment with curative intent.